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| Name | Class |
|---|---|
| University Grenoble Alps | OTHER |
| Università degli Studi di Trento | OTHER |
| Medical University Innsbruck | OTHER |
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The aim of the current study is to evaluate under blinded conditions, both in a simulated environment and during helicopter flight, the effect of a rapid (within 20 minutes) exposure to altitude (4000 m asl) on physiological parameters and selected cognitive domains, in providers operating in helicopter emergency medical service (HEMS) exposed to hypobaric hypoxia or to hypobaric normoxia (H0: cognitive effects under hypobaric hypoxia = cognitive effects under hypobaric normoxia). Simulated environment will allow to control different factors. The parallelism between a study branch conducted in a simulated environment and another one conducted under a real-life condition will allow to evaluate the additive effects on additional stressor factors (processive and systemic ones).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypobaric normoxia | Experimental | Altitude exposure in hypobaric normoxic condition |
|
| Hypobaric hypoxia | Sham Comparator | Altitude exposure in hypobaric hypoxic condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Altitude exposure in hypobaric normoxic condition | Other | Altitude exposure with oxygen supplementation to achieve normoxia at altitude |
|
| Measure | Description | Time Frame |
|---|---|---|
| Psychomotor Vigilance Test - PVT | Changes in reaction time using a computer-based test (PVT) | Changes from baseline (T0) to altitude measurement (respectively after 5 min - T1 and after 30 min - T2) |
| Digit-Symbol Substitution Task - DSST | Changing in processing speed using a computer based test (DSST) | Changes from baseline (TC0) to altitude measurement (respectively after 5 min - TC1 and after 30 min - TC2) |
| 2-back Test | Changing in working memory using a computer based test (2-back test) | Changes from baseline (TC0) to altitude measurement (respectively after 5 min - TC1 and after 30 min - TC2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giacomo Strapazzon, MD PhD | Eurac Research, Institute of Mountain Emergency Medicine | Principal Investigator |
| Marika Falla, MD PhD | University of Trento, Center for Mind/Brain Sciences - CIMeC | Principal Investigator |
| Michiel van Veelen, MD | Eurac Research, Institute of Mountain Emergency Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurac Research, Institute of Mountain Emergency Medicine | Bolzano | BZ | 39100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34019081 | Background | Basner M, Moore TM, Nasrini J, Gur RC, Dinges DF. Standardization of psychomotor vigilance testing methods and reporting. Sleep. 2021 Jul 9;44(7):zsab114. doi: 10.1093/sleep/zsab114. No abstract available. | |
| 29596018 | Background | Brodmann Maeder M, Brugger H, Pun M, Strapazzon G, Dal Cappello T, Maggiorini M, Hackett P, Bartsch P, Swenson ER, Zafren K. The STAR Data Reporting Guidelines for Clinical High Altitude Research. High Alt Med Biol. 2018 Mar;19(1):7-14. doi: 10.1089/ham.2017.0160. Epub 2018 Feb 9. |
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Interventional, non-pharmacological, randomized, controlled, double-blinded, cross-over
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| Altitude exposure in hypobaric hypoxic condition | Other | Altitude exposure with air supplementation to obtain a sham comparator arm |
|
| 12602449 | Background | Cable GG. In-flight hypoxia incidents in military aircraft: causes and implications for training. Aviat Space Environ Med. 2003 Feb;74(2):169-72. |
| Background | EASA. https://www.easa.europa.eu/document-library/notices-of-proposed-amendment/npa-2018-04. (2018). |
| 33995130 | Background | Falla M, Papagno C, Dal Cappello T, Vogele A, Hufner K, Kim J, Weiss EM, Weber B, Palma M, Mrakic-Sposta S, Brugger H, Strapazzon G. A Prospective Evaluation of the Acute Effects of High Altitude on Cognitive and Physiological Functions in Lowlanders. Front Physiol. 2021 Apr 28;12:670278. doi: 10.3389/fphys.2021.670278. eCollection 2021. |
| 35640630 | Background | Falla M, Hufner K, Falk M, Weiss EM, Vogele A, Jan van Veelen M, Weber B, Brandner J, Palma M, Dejaco A, Brugger H, Strapazzon G. Simulated Acute Hypobaric Hypoxia Effects on Cognition in Helicopter Emergency Medical Service Personnel - A Randomized, Controlled, Single-Blind, Crossover Trial. Hum Factors. 2024 Feb;66(2):404-423. doi: 10.1177/00187208221086407. Epub 2022 May 31. |
| Background | Hart, S., and Staveland, L. (1988). "Development of NASA-TLX (task load index) - results ofempirical and theoretical research," in HumanMental Workload, eds P. Hancock and N. Meshkati (Amsterdam: Springer), 139-183. doi: 10.1016/ s0166- 4115(08)62386- 9. |
| 18328973 | Background | Hinkelbein J, Glaser E. Evaluation of two oxygen face masks with special regard to inspiratory oxygen fraction (FiO2) for emergency use in rescue helicopters. Air Med J. 2008 Mar-Apr;27(2):86-90. doi: 10.1016/j.amj.2007.07.005. |
| 28753037 | Background | Mrakic-Sposta S, Vezzoli A, Malacrida S, Falla M, Strapazzon G. "Direct" and "Indirect" Methods to Detect Oxidative Stress During Acute or Chronic High-Altitude Exposure. High Alt Med Biol. 2017 Sep;18(3):303-304. doi: 10.1089/ham.2017.0067. Epub 2017 Jul 28. No abstract available. |
| 30556701 | Background | Nowacki J, Heekeren HR, Deuter CE, Joerissen JD, Schroder A, Otte C, Wingenfeld K. Decision making in response to physiological and combined physiological and psychosocial stress. Behav Neurosci. 2019 Feb;133(1):59-67. doi: 10.1037/bne0000288. Epub 2018 Dec 17. |
| 19161909 | Background | Wilson MH, Newman S, Imray CH. The cerebral effects of ascent to high altitudes. Lancet Neurol. 2009 Feb;8(2):175-91. doi: 10.1016/S1474-4422(09)70014-6. |
| 39075543 | Derived | Falla M, van Veelen MJ, Falk M, Weiss EM, Roveri G, Mase M, Weber B, Randi A, Brugger H, Hufner K, Strapazzon G. Effect of oxygen supplementation on cognitive performance among HEMS providers after acute exposure to altitude: the HEMS II randomized clinical trial. Scand J Trauma Resusc Emerg Med. 2024 Jul 29;32(1):65. doi: 10.1186/s13049-024-01238-6. |